FDA WARNING_LETTER - Sadboy LLC - October 07, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Edward Myers and Robert Wiley of Philly Vape Society, LLC, following a review of their website, https://phillyvapesociety.com. The FDA determined that e-liquid products offered for sale, specifically "Sadboy E-liquid Pumpkin Cookie 100ml" and "Sadboy E-liquid Key Lime Cookie 100ml," are tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

These products are considered "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these e-liquid products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6).

The firm is a registered manufacturer with over 40 products listed with FDA. A Premarket Tobacco Product Application (PMTA) (STN PM0003534) submitted on September 9, 2020, covering 53 products, received a Marketing Denial Order on September 3, 2021. The FDA emphasizes that new tobacco products on the market without premarket authorization are unlawful and subject